Perioperative Epidural Trial (POET) Pilot Study

This study has been completed.

First Received: September 18, 2005 Last Updated: September 24, 2008 History of Changes

Sponsors and Collaborators:	University of British Columbia Canadian Institutes of Health Research (CIHR)
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00221260

Purpose

To investigate if the use of perioperative neuraxial blockade reduces post-operative mortality and cardiorespiratory events compared to intraoperative general anesthesia AND postoperative IV narcotic analgesia. This is a feasibility study to determine if recruitment and execution of the protocol could be done in a timely manner in a much larger trial

Condition	Intervention
Post Operative Pain Control	Procedure: anesthesia

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Perioperative Epidural Trial (POET) Pilot Study

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	September 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Intraoperative general anesthesia AND postoperative IV narcotic analgesia.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects at high risk of cardio-respiratory complications post operatively.

Exclusion Criteria:

Contraindication to epidural anesthesia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221260

Locations

Canada, British Columbia
Vancouver General Hospital, Clinical Health Research Unit
Vancouver, British Columbia, Canada, V5Z 1L8

Sponsors and Collaborators

University of British Columbia

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Peter Choi, MD

University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia ( Dr. Peter Choi )
Study ID Numbers:	C04-0078, 04-3046
Study First Received:	September 18, 2005
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00221260 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Analgesia
anesthesia

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Central Nervous System Depressants
Anesthetics

Narcotics
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Postoperative Complications
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Pain
Central Nervous System Agents
Pharmacologic Actions
Pain, Postoperative

ClinicalTrials.gov processed this record on May 06, 2009